A Study to Compare the Oral Bioavailability of Single Doses of Two Vapendavir Drug Formulations in Healthy Volunteers

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase 1 study aims to determine the oral bioavailability of a single dose of a new vapendavir tablet formulation and compare it to that of the previous vapendavir capsule formulation. The safety of both drug products will also be assessed.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biota Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• Must be male or female between 18 and 55 years of age (inclusive) with BMI between 18 and 30 kg/m2 (inclusive), and weight ≥50 kg at the time of screening

• Capable of giving written informed consent

• Subject is able to understand and comply with the protocol requirements, instructions and restrictions

• Healthy on the basis of physical examination, medical history, medication usage, VS, ECGs, and clinical laboratory tests

• Female subjects must be of non-childbearing potential

• Male subjects must agree to use a double barrier method of birth control

Exclusion Criteria:

• Positive results for Hepatitis B, Hepatitis C, or HIV

• Frequent use of tobacco products, including cigarettes, cigars, chewing tobacco

• A medical history of significant hematological, gastrointestinal, respiratory, renal, hepatic, cerebrovascular, immunologic, psychiatric or cardiovascular disease or event; Current or recent respiratory infection

• Presence or history of significant allergy

• Clinically significant abnormalities noted on ECG

• Screening vital signs representing sustained elevated blood pressure

• Presence of significant gastrointestinal abnormalities

• Safety laboratory abnormalities noted at screening which are clinically significant

• Current or defined history of abuse of alcohol or illicit drugs

• A positive pregnancy test at screening

• Poor vein access or fear of venipuncture or sight of blood